FDA Approvals, News & Updates

On November 6, 2017, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with ALK mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori).

On October 31, 2017, the FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for the treatment of adults with mantle-cell lymphoma (MCL) who have received at least 1 previous therapy. The FDA granted acalabrutinib priority review and breakthrough therapy and orphan drug designations for this indication.

On September 28, 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2-­negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting.

On October 18, 2017, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma.

On September 14, 2017, the FDA granted accelerated approval to copanlisib (Aliqopa; Bayer Healthcare) for the treatment of adults with relapsed follicular lymphoma who have received ≥2 previous systemic therapies. Copanlisib received priority review and an orphan drug designation for this indication.

A brief overview of new therapies approved by the FDA between August 1 and August 7, 2017.

A brief overview of cancer drugs approved by the FDA between March 15, 2017, and May 30, 2017.